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Recall Observatory FDA recall evidence

Device product

Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04

Z-0918-2018

October 03, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79206
Status
Terminated
Classification
Class II
Quantity
457
Official record key
device-enforcement:Z-0918-2018

Official wording

Reason: The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications.

Code information: All lots

Distribution pattern: Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications.

Field note

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